Swiss medical technology firm MedAlliance has completed the recruitment of more than 1,000 patients in its Selution DeNovo coronary randomised trial.
The trial is designed to compare the use of the new sirolimus drug-eluting balloon (DEB Selution) against a limus drug-eluting stent (DES) treatment strategy.
Selution Sustained Limus Release (SLR) features an angioplasty balloon coated with MicroReservoirs that contain a mixture of the anti-restenotic drug sirolimus and biodegradable polymer.
These MicroReservoirs offer controlled and sustained release of the drug for more than 90 days in a manner similar to a DES but without leaving a metal scaffold behind.
Claimed to be the largest DEB study ever undertaken, the Selution DeNovo trial is being conducted at around 70 participating sites across 15 countries.
To reflect present medical practice and lower bias, patients in the trial were randomised prior to any vessel preparation.
The study’s objectives include the demonstration of non-inferiority at both one and five years, as well as superiority for target vessel failure (TVF) at five years, stated the company.
MedAlliance chairman and CEO Jeffrey Jump said: “This trial has the potential to change medical practice, not only in Europe but also in the US, China and Japan, benefitting patients around the globe.
“We are currently enrolling US patients in our coronary ISR IDE and BTK studies in the US and Europe.”
In May 2020, the company received CE mark approval for the Selution SLR to treat coronary artery disease.
MedAlliance is claimed to be the first DEB company to receive breakthrough designation status from the US Food and Drug Administration (FDA).
Besides the below-the-knee (BTK) and superficial femoral artery (SFA) indications for which the firm received FDA investigational device exemption (IDE) approval in May and August last year, MedAlliance secured coronary in-stent restenosis (ISR) IDE approval in October last year and de novo coronary artery lesions approval in January.
